- Device
- Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis/Theon Pericardial Mitral Bioprosthesis with ThermaFix
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S185
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2018-12-01
- Decision code
- OK30
- Date received
- 2018-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of the Carpentier-Edwards PERIMOUNT Model 6900P sewing ring in the Carpentier-Edwards PERIMOUNT Model 6900PTFX valve.